FDA Inspection
Sanofi Winthrop IndustrieSanofi Winthrop Industrie – FDA Inspection, Sep 24, 2026
Record Details
This FDA Inspection record concerns Sanofi Winthrop Industrie, with an inspection on September 24, 2026, issued by the Office of Inspections and Investigations, covering biologics.
- Company
- Sanofi Winthrop Industrie
- Inspection Date
- September 24, 2026
- Product Type
- Biologics
View Company Profile
ID · 91f598c6-a7a9-4588-96bf-6c7822312fc4
Inspection Facts
- Inspection number
- 1337194
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Sanofi Winthrop Industrie
11| Date | Classification | Office | Project area |
|---|---|---|---|
| April 25, 2023 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| February 7, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 1, 2019 | Not classified | Office of Inspections and Investigations | |
| May 25, 2018 | Not classified | Office of Inspections and Investigations | |
| February 14, 2017 | Not classified | Office of Inspections and Investigations |
Other documents for Sanofi Winthrop Industrie
- FDA Inspection 1206033 - 2023-04-25
- FDA Inspection 1133485 - 2020-02-07
- FDA Inspection 1086137 - 2019-03-01
- FDA Inspection 1058039 - 2018-05-25
- FDA Inspection 1001237 - 2017-02-14
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